Cell and Gene Therapy Catapult Annual Review

Over the last year, the advanced therapies industry has continued to develop and deploy enhanced processes coupled with automation and robotic technologies, including in larger scale settings. These technologies are making processes more efficient and cost-effective whilst delivering high-quality, safe products.

As manufacturing output grows, ensuring that analytical and quality control testing keeps pace is critical. Investment in nextgeneration automated testing technologies, designed for speed, accuracy, sensitivity and real-time data feedback, will be essential to avoid this becoming a bottleneck. 

Digital technologies are increasingly important in reducing development timelines and increasing certainty of manufacturing outcomes. Integrating data platforms with AI and machine learning tools is key, and their wider deployment into larger scale manufacturing will be crucial as the industry continues to advance.

New technologies also offer benefits for environmental sustainability. Digital tools, including digital twins, can model the environmental impact of therapy  production and identify opportunities to reduce it, helping the industry move towards more efficient, lower-footprint processes.

The demand for manufacturing capacity in the UK to support clinical trials and commercial supply continues to be challenging, driven by shifting  market dynamics and the increasing complexity of the ATMP pipeline. To ensure that as many patients as possible can access these treatments, the sector must continue to embrace and shape new regulatory innovations, including more agile operating models, high-throughput manufacturing, and Quality Control (QC) testing technologies.

Over the years ahead, there is a need for the industry to focus on scaling reliable manufacturing, reducing vein-to-vein time, and managing complex and highly specialised supply chains. The deployment of new technologies and digital systems that enhance efficiency and support the expansion of UK manufacturing 
capacity will be needed to meet these demands. This progress will also require an agile workforce equipped with the skills needed to operate and integrate these evolving technologies.

The environment in the UK for cell and gene therapies continues to evolve, with regulatory reform, continued momentum in clinical trials, and efforts to ensure patients can access advanced therapies.

The Medicines and Healthcare products Regulatory Agency (MHRA) has been advancing reforms to modernise the framework for advanced therapies, including work on decentralised manufacturing models that enable production closer to clinical settings. Another key regulatory priority has been faster approvals. The government has targeted a reduction in clinical trial set-up times to under 150 days from application to trial initiation.

In parallel, coordinated efforts between regulators, researchers and patient groups are aiming to improve pathways for rare disease treatments, where significant unmet need remains. 

The UK continues to be one of the most active locations globally for advanced therapy clinical trials, reflecting its competitiveness as a location for early-stage and innovative research.

The UK has many of the ingredients required to strengthen its position as a global leader in cell and gene therapies. By aligning scientific excellence with  coordinated action across research, industry and the healthcare system, the country can convert laboratory breakthroughs into widely accessible treatments that improve outcomes while reducing long-term system pressures.

Ensuring the UK is an attractive place to start, grow and scale cell and gene therapy companies in is equally vital. This requires targeted support to help companies move from early-stage research to commercial production. 

At the same time, closer alignment between developers, regulators and the healthcare system can help speed up access to clinically effective and cost-efficient treatments. While regulation should continue to shift to reflect the innovative, often one-time, nature of these therapies. 

CGT Catapult is working closely with partners across this ecosystem to tackle these challenges and unlock the full health and economic potential of advanced therapies across the UK, in pursuit of a shared ambition with Innovate UK to turn the UK’s breakthrough ideas into globally-leading businesses.